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Official Title: Phase I Study of Mescaline Grape Extract (ME) in Advanced Malignancy NCT02583269 Preapproved Date: 11/14/17Comprehensive Cancer Center of Wake Forest University (CCFU) CCFU 01815PHASE

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What is phase 1 study of?

Phase 1 study is a clinical trial conducted on a small group of people to assess the safety and tolerability of a new drug.

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The sponsoring company or organization conducting the clinical trial is required to file the phase 1 study.

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Phase 1 study is typically filled out by the principal investigator or study coordinator according to regulatory guidelines.

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The purpose of phase 1 study is to determine the safety, tolerability, and pharmacokinetics of a new drug in humans.

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Phase 1 study must report on the study design, participant demographics, drug administration, adverse events, and study results.

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